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A Single Dose Study Investigating the Elimination as Well as the Tolerability of PD 0332334 in Healthy Subjects as Compared to Patients With Impaired Kidney Function.

Sponsor
Pfizer (Industry)
Overall Status
Terminated
CT.gov ID
NCT00721422
Collaborator
(none)
16
Enrollment
2
Locations
4
Arms
6
Duration (Months)
8
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

  1. To investigate the effect of kidney function on the elimination of a single dose of PD 0332334 from the body.

  2. To investigate the safety and tolerability of a single dose of PD 0332334 in patients with impaired kidney function.

Condition or Disease Intervention/Treatment Phase
  • Drug: PD 0332334
  • Drug: PD 0332334
  • Drug: PD 0332334
  • Drug: PD 0332334
 Phase 1

Detailed Description

Additional Study Purpose Details: Investigation of the pharmacokinetics, safety, and tolerability of a single dose of PD 0332334 in patients with impaired renal function.

On February 23rd 2009, a decision to terminate further development for PD 0332334 was communicated to investigators in this study. The decision to terminate this study was not based on any safety concerns.

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Official Title:
A Phase 1, Open-Label, Single Dose Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of PD 0332334 In Subjects With Various Degrees Of Renal Function
Study Start Date :
Aug 1, 2008
Actual Primary Completion Date :
Feb 1, 2009
Actual Study Completion Date :
Feb 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1-Normal

Drug: PD 0332334
50 mg (two 25 mg capsules), single, oral dose
Other Names:
  • imagabalin

    		•
    Experimental: Group 2-Mild

    Drug: PD 0332334
    50 mg (two 25 mg capsules), single, oral dose
    Experimental: Group 3-Moderate

    Drug: PD 0332334
    50 mg (two 25 mg capsules), single, oral dose
    Experimental: Group 4-Severe

    Drug: PD 0332334
    50 mg (two 25 mg capsules), single, oral dose

    Outcome Measures

    Primary Outcome Measures

    1. maximum plasma concentration (Cmax), time of maximum plasma concentration (Tmax), and apparent clearance from plasma (CL/F) [1 day]

    2. amount of PD 0332334 eliminated unchanged in urine during the 96-hour collection period (Ae96) [5 days]

    3. PD 0332334 area under the curve from 0 to infinity (AUCinf), PD 0332334 area under the curve from 0 to last quantifiable concentration (AUClast), [5 to 17 days depending on cohort]

    4. PD 0332334 renal clearance (CLr), apparent volume of distribution (Vz/F), terminal half life (t1/2), [5 to 17 days depending on cohort]

    Secondary Outcome Measures

    1. Adverse events, ECG, physical exams, clinical safety laboratory, and vital signs [5 to 17 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    Healthy volunteers OR subjects with kidney impairment

    Exclusion Criteria:

    1. Receiving hemodialysis

    2. clinically significant or unstable medical disease other than kidney disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Investigational Site Cypress California United States 90630
    2 Pfizer Investigational Site Miami Florida United States 33169

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00721422
    Other Study ID Numbers:
    • A5361023
    First Posted:
    Jul 24, 2008
    Last Update Posted:
    Feb 17, 2010
    Last Verified:
    Feb 1, 2010
    Keywords provided by , ,
    Pharmacokinetics of PD 0332334 in subjects with renal insufficiency
    Additional relevant MeSH terms:
    Renal Insufficiency

    Study Results

    No Results Posted as of Feb 17, 2010